诚意药业：二十碳五烯酸乙酯软胶囊已获得《药品注册证书》，目前生产车间正准备符合性检查

Core Viewpoint - The company has successfully completed the registration process for Eicosapentaenoic Acid Ethyl Ester capsules and is preparing for compliance checks to begin production [1] Group 1: Regulatory Compliance - The company’s raw material production facility has passed multiple GMP audits by Australia's TGA since 1998, with the most recent GMP certificate obtained in January 2025 [1] - The facility has also successfully undergone on-site audits and re-evaluations by the US FDA, indicating its capability to produce the capsules in a GMP-certified environment [1] Group 2: Production Readiness - The Eicosapentaenoic Acid Ethyl Ester soft capsule has received the Drug Registration Certificate, and the production workshop is preparing for compliance checks [1] - Production can commence immediately after passing the compliance checks [1]